NCT04809532

Brief Summary

Objective: To compare Trans Abdominis Plane block in providing post cesarean analgesia with control group, in terms of mean postoperative use of Opioids. Study design: Randomized controlled trial. Place and duration Department of Anesthesiology, Combined Military Hospital, Sargodha, 25th February 2021 to 25th April 2021. Materials and methods: A total of 60 female patients, who are planned to undergo elective c section and aged between 20-45 will be selected randomly and divided into two groups ( A and B) with 30pts each group. In Group A, at the end of surgery, TAP block will be given with 20ml of 0.25%bupvicaine via ultrasound guided sub-costal approach on both sides of midline. Time of TAP block will be recorded as time 0. Our outcomes will be: mean postoperative consumption of opioids and VAS score within 24hrs of surgery. Independent t test will be used to compare group A and B in terms of mean usage of tramadol within 24hrs of surgery. P value \<0.05 will be considered statistically significant.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 8, 2021

Last Update Submit

March 19, 2021

Conditions

Keywords

Transverse abdominis plane blockcesarean sectionpostoperative use of opioids

Outcome Measures

Primary Outcomes (1)

  • postoperative consumption of opioids

    questionnaire will be filled 24hours after the surgery by trainee anesthesia and he/she will document the total consumption of intravenous tramadol after surgery

    24hours after surgery

Study Arms (2)

Group A

EXPERIMENTAL

Transverse abdominis plane (TAP ) block via 20ml 0.25% bupvicaine on both sides of midline will be given at end of surgery

Procedure: Transverse abdominis plane (TAP) blockDrug: BupivacainDrug: Tramadol

Group B

NO INTERVENTION

At the end of surgery, no additional intervention will be done.

Interventions

Ultrasound guide bilateral TAP block at end of cesarean section

Group A

20ml 0.25% bupvicaine

Group A

intravenous tramadol

Group A

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20 and 45 years
  • Elective cesarean
  • Fit to undergo surgery under spinal anesthesia

You may not qualify if:

  • Patients who will have
  • Any contraindication to spinal anesthesia
  • ASA class III and IV
  • Known Allergic to local anesthetic
  • Eclampsia
  • Placenta accreta/percretra

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatrics

Rawalpindi, Punjab Province, 68000, Pakistan

RECRUITING

Madiha Ahmed

Islamabad, 45710, Pakistan

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Dental OcclusionBupivacaineTramadol

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesLipids

Central Study Contacts

Arshad Khushdil, FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 22, 2021

Study Start

February 25, 2021

Primary Completion

April 25, 2021

Study Completion

April 30, 2021

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations